KalVista Initiates KONFIDENT-KID Trial for On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Children Aged 2 to 11

Rhea-AI Summary

KalVista Pharmaceuticals (NASDAQ: KALV) has launched the KONFIDENT-KID trial to evaluate sebetralstat, an oral plasma kallikrein inhibitor, for treating hereditary angioedema (HAE) attacks in children aged 2 to 11. The open-label trial will enroll 24 children across seven countries in North America, Europe, and Asia. Over one year, it will gather safety, pharmacokinetic, and efficacy data using a pediatric oral disintegrating tablet formulation of sebetralstat. If successful, sebetralstat could become the first oral on-demand therapy for this age group, addressing a significant unmet need, as the current option is an intravenous treatment.

Positive

• Initiation of the KONFIDENT-KID trial earlier than anticipated shows strong support from physicians and caregivers.
• If approved, sebetralstat will be the first oral on-demand therapy for children aged 2 to 11 with HAE.
• The trial involves multiple countries, enhancing the diversity and robustness of the data.

Negative

• None.

Insights

Medical Research Analyst

The initiation of the KONFIDENT-KID clinical trial by KalVista Pharmaceuticals represents a significant step in the treatment of hereditary angioedema (HAE) in pediatric patients. Oral medications are generally easier to administer, especially in young children who may have issues with intravenous treatments. Sebetralstat, as an oral plasma kallikrein inhibitor, could potentially simplify and improve the management of HAE attacks in children.

In terms of safety and efficacy, collecting data over one year will provide valuable insights into how the drug performs in real-world scenarios. The inclusion of a proprietary pediatric oral disintegrating tablet (ODT) formulation is also noteworthy. Such formulations are designed to dissolve quickly in the mouth, which can be particularly beneficial for children who may struggle with swallowing tablets.

Short-term, this news might not immediately impact the stock market since clinical trials are time-consuming and results are pending. However, long-term, if the trial demonstrates positive results, KalVista would have a unique product in a largely unmet market, likely resulting in increased market share and revenue growth. This could be highly promising for investors focusing on biotech stocks with innovative solutions in niche markets.

Financial Analyst

From a financial perspective, the initiation of the KONFIDENT-KID trial can be viewed as a strategic move by KalVista Pharmaceuticals. Bringing a novel, oral treatment to market for pediatric hereditary angioedema (HAE) fills a significant gap. Current treatments are intravenous, which can be challenging for children and their caregivers. This innovation could potentially reduce hospital visits and associated healthcare costs, making it a financially attractive option.

KalVista has positioned itself to potentially capture a significant share of a niche market. The fact that the trial is already underway in seven countries suggests the company is committed to a broad, international market reach. If sebetralstat is approved, it could lead to substantial revenue growth, as the pediatric HAE market is currently underserved.

However, investors should be cautious. Clinical trials come with inherent risks, including the possibility of adverse safety profiles or lack of efficacy. Additionally, the trial's international scope will incur higher operational costs, impacting short-term financials. Yet, the long-term potential rewards might outweigh these risks if the drug proves successful.

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the initiation of the open-label KONFIDENT-KID clinical trial of sebetralstat, a novel, oral, plasma kallikrein inhibitor, in pediatric patients with hereditary angioedema (HAE). The trial will enroll approximately 24 children aged 2 to 11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic, and efficacy data for each patient for up to one year and will feature a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat.

“We are pleased to announce that the KONFIDENT-KID trial has started earlier than previously anticipated,” said Ben Palleiko, Chief Executive Officer of KalVista. “This timeline reflects the high level of excitement among physicians, caregivers, and our patient advocacy partners regarding the potential of sebetralstat to treat children with HAE. Currently, the only approved on-demand treatment for this population is administered intravenously, making this a critical area of unmet need for people living with HAE.”

If approved, sebetralstat would be the first oral on-demand therapy in pediatric patients aged 2 – 11 years, and only the second FDA-approved on-demand therapy of any type in this population.

For more information on KONFIDENT-KID, please visit our listing on clinicaltrials.gov.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the UK, Europe, and Japan later in 2024.

For more information about KalVista, please visit www.kalvista.com.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA or other international regulatory agencies, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development within our expected timelines or at all, our success in engaging with potential commercial partners, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, our ability to commence pediatric trials of sebetralstat and develop an ODT formulation, the future progress and potential success of our oral Factor XIIa program, our ability to reduce spending on discovery and preclinical activities, and our expectation to become cash flow positive. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240627071012/en/

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What is the KONFIDENT-KID trial?

The KONFIDENT-KID trial is an open-label clinical study evaluating sebetralstat, an oral plasma kallikrein inhibitor, for treating hereditary angioedema attacks in children aged 2 to 11.

When did KalVista Pharmaceuticals start the KONFIDENT-KID trial?

KalVista Pharmaceuticals announced the initiation of the KONFIDENT-KID trial recently.

What age group is being targeted in the KONFIDENT-KID trial?

The KONFIDENT-KID trial targets children aged 2 to 11 years.

How many children will participate in the KONFIDENT-KID trial?

Approximately 24 children will participate in the KONFIDENT-KID trial.

What is the significance of sebetralstat in the KONFIDENT-KID trial?

Sebetralstat is a novel oral plasma kallikrein inhibitor that, if approved, could become the first oral on-demand therapy for HAE attacks in children aged 2 to 11.

Which countries are participating in the KONFIDENT-KID trial?

The KONFIDENT-KID trial will be conducted across seven countries in North America, Europe, and Asia.

Why is the KONFIDENT-KID trial important for children with hereditary angioedema?

The trial addresses a critical unmet need as the current approved on-demand treatment for HAE in this age group is intravenous, whereas sebetralstat offers an oral alternative.

What data will be collected in the KONFIDENT-KID trial?

The trial will collect safety, pharmacokinetic, and efficacy data over one year.

What formulation of sebetralstat is used in the KONFIDENT-KID trial?

The trial uses a pediatric oral disintegrating tablet (ODT) formulation of sebetralstat.

What is the stock symbol for KalVista Pharmaceuticals?

The stock symbol for KalVista Pharmaceuticals is KALV.